{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "SANTA CLARA", "manufacturer_contact_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_contact_pcity": "40852321", "event_type": "Injury", "report_number": "2955842-2026-02284", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20260127", "manufacturer_address_2": "", "pma_pmn_number": "K143132", "date_of_event": "20251218", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "95051", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "4085232100", "noe_summarized": "1", "manufacturer_contact_l_name": "NIELSON", "source_type": [ "Other", "Foreign", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "95051", "manufacturer_g1_state": "CA", "reporter_country_code": "CH", "manufacturer_contact_area_code": "", "date_added": "20260127", "manufacturer_contact_f_name": "IZABEL", "device_date_of_manufacturer": "20241121", "previous_use_code": "I", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "174230", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20260127", "brand_name": "DA VINCI", "generic_name": "HARMONIC ACE", "manufacturer_d_name": "INTUITIVE SURGICAL, INC", "manufacturer_d_address_1": "3410 CENTRAL EXPRESSWAY", "manufacturer_d_address_2": "", "manufacturer_d_city": "SANTA CLARA", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "95051", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "95051", "device_operator": "HEALTH PROFESSIONAL", "model_number": "480275-10", "catalog_number": "480275", "lot_number": "L10241121 0171", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "device_report_product_code": "NAY", "device_age_text": "DA", "device_evaluated_by_manufacturer": "Y", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ], "product_problems": [ "Detachment of Device or Device Component" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/22/2026", "mfr_report_type": "Initial", "manufacturer_contact_country": "US", "date_changed": "20260814", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20260127", "sequence_number_treatment": [ "DA VINCI INSTRUMENTS AND ACCESSORIES" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "NA", "patient_sex": "Unknown", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20260601", "initial_report_to_fda": "No", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "SANTA CLARA", "mdr_report_key": "24188651", "removal_correction_number": "N/A", "number_devices_in_event": "", "date_manufacturer_received": "20260107", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "Other" ], "manufacturer_g1_zip_code": "95051", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "INTUITIVE SURGICAL, INC", "adverse_event_flag": "N", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "Y", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "391337213", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, HARMONIC ACE INSTRUMENT THE BLADE WAS FOUND BROKEN. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE, AND NO DAMAGE OR ANYTHING UNUSUAL WAS OBSERVED DURING THE PRE-OPERATIVE CHECK. HOWEVER, DURING THE PROCEDURE, WHILE GRASPING TISSUE, A FRAGMENT OF THE DEVICE FELL INSIDE THE PATIENT. THE SURGEON BELIEVES THAT THE ISSUE MAY HAVE BEEN RELATED TO THE INSTRUMENT'S QUALITY. THE INSTRUMENT HAD BEEN IN USE FOR APPROXIMATELY AN HOUR BEFORE THE PROBLEM OCCURRED, AND SOME FUNCTIONALITY ISSUES WERE NOTICED DURING THE SURGERY, ALTHOUGH THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENTS OR HARD MATERIALS AT ANY POINT. THE FRAGMENT FELL INSIDE THE PATIENT DURING AN INSTRUMENT TIP OR ACCESSORY COLLISION, AND PRIOR TO BREAKAGE, THE INSTRUMENT HAD BEEN REMOVED WITH ITS WRIST STRAIGHTENED; STAFF DID NOT FEEL ANY RESISTANCE DURING REMOVAL. UPON FINAL REMOVAL OF THE INSTRUMENT, THE WRIST WAS STRAIGHTENED AND AGAIN, NO RESISTANCE WAS FELT AS IT WAS WITHDRAWN THROUGH THE CANNULA. NO DAMAGE TO THE CANNULA WAS OBSERVED, BUT THE STAFF DID NOTICE FURTHER DAMAGE TO THE INSTRUMENT AFTER REMOVAL. THE FRAGMENT WAS RETRIEVED BY THE ASSISTANT USING FORCEPS, AND ALL FRAGMENTS WERE VISUALLY CONFIRMED TO HAVE BEEN RECOVERED. NO ADDITIONAL SURGICAL PROCEDURES¿SUCH AS LAPAROSCOPY OR CONVERSION TO OPEN SURGERY¿WERE NECESSARY FOR FRAGMENT REMOVAL, NOR WERE ANY POST-OPERATIVE TESTS LIKE X-RAY OR ULTRASOUND PERFORMED TO CHECK FOR RESIDUAL FRAGMENTS. THE ENTIRE PROCEDURE WAS COMPLETED ROBOTICALLY WITHOUT THE NEED TO ABORT OR SWITCH TO A DIFFERENT TECHNIQUE. THERE WERE NO ADDITIONAL INJURIES TO THE PATIENT AS A RESULT OF THIS INCIDENT, AND THE PATIENT HAS NOT RETURNED TO THE HOSPITAL FOR ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT. THE INSTRUMENT AND ITS ACCESSORY ARE AVAILABLE TO BE RETURNED TO INTUITIVE SURGICAL (ISI) FOR EVALUATION, AND ALL RETRIEVED FRAGMENTS WILL ALSO BE INCLUDED IN THE RETURN. NO PHOTOGRAPHIC IMAGES OF THE DEVICE OR VIDEO RECORDINGS OF THE PROCEDURE WERE AVAILABLE FOR ISI REVIEW." }, { "mdr_text_key": "391337215", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THE HARMONIC ACE INSTRUMENT HAS NOT BEEN RECEIVED FOR FAILURE ANALYSIS EVALUATION." }, { "mdr_text_key": "403360759", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "REFER TO H11 FOR FOLLOW-UP INFORMATION." }, { "mdr_text_key": "403360762", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE DA VINCI PRODUCT WITH AN ALLEGED ISSUE TO PERFORM FAILURE ANALYSIS. THE INSTRUMENT WAS FOUND TO HAVE ONE BLADE BROKEN AT THE BASE. A PIECE APPROXIMATELY 14.33 MM X 2.14 MM WAS FOUND TO BE BROKEN OFF, CONFIRMING THAT A FRAGMENT DETACHED FROM THE INSTRUMENT. THE BROKEN PIECE WAS RETURNED. A REVIEW OF THE SITE'S SYSTEM LOGS FOR THE REPORTED PROCEDURE DATE WAS CONDUCTED. INVESTIGATION REVEALED THERE WERE NO RELATED SYSTEM ERRORS TO HAVE OCCURRED DURING THE SURGICAL PROCEDURE THAT WOULD HAVE LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED COMPLAINT." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "3410 CENTRAL EXPRESSWAY", "distributor_zip_code": "", "manufacturer_contact_postal_code": "95051", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "06/01/2026" } ] }